At Mylab, we’re on a mission to transform diagnostics through innovative software solutions that make a real difference in healthcare. Our solutions empower professionals, improve patient outcomes, and set new standards in health technology. Every line of code, every feature, every decision matters, because ultimately, lives depend on it.  

To make this vision a reality, we need curious minds and passionate hearts: people who want to lead, innovate, and grow. That’s where you come in.  

Your impact as a Lead Quality Engineer

As our Lead Quality Engineer, you'll own and lead defined quality management system (QMS), Regulatory Affairs and IVDR related processes - making sure that, within your own responsibility area, our Laboratory Information System (LIS) and related healthcare solutions meet all applicable regulatory, quality, and data security standards.

This is a role for someone who turns plans into action and regulations into workable processes. You have deep knowledge of the relevant industry standards, stay current as they evolve, and translate them into something the rest of the organization can apply in daily work. When you come along, you bring deep, hands-on competence with already proven record of success.

Lead Quality Engineer proactively and continuously improves processes and ways of working rather than just applying them, including creating compliant and clear documentation. When complex issues come up, you are committed to finding the most efficient solutions, and you are motivated to identify and eliminate waste in processes. In this role, you also give your contribution to the quality and compliance strategy in your own expertise area.

You'll own your work end-to-end, but the role is built on close collaboration with product, software development, delivery teams, and beyond. Helping colleagues build their own quality thinking into their daily work is a core part of the job, and you genuinely enjoy that side of it.

Why it matters: we are working toward one shared goal: empowering outcome-based healthcare through data-driven, reliable solutions. Quality isn't a checkbox at Mylab. It's how patients and clinicians can truly trust what we build.

In this role, you report to Quality & Compliance Manager.

What you bring to the table

• A strong background of more than 5 years in quality assurance/management and/or regulatory affairs. Along with the experience, you also have a degree in higher education.

• Expert level understanding and application of ISO13485 and other QMS standards, alongside thorough knowledge on IVDR (2017/746) and/or MDR (2017/745) and MDCG guidances, and related documentation, IEC 62304 and EU and national laws, standards and other regulations related but not limited to (IVD) medical devices and LIS.

• Strong expertise in risk management in accordance with ISO 14971 standard and applying risk management tools.

• Several years of Lead Auditor experience.

• A proven ability to apply knowledge in regulatory work, quality management systems and data security in the software product industry.

• Familiarity with Agile methods and software processes.

• Experience and excitement to leverage AI tools and solutions in your work.

Why join us? 

At Mylab, our efforts directly improve healthcare. We believe good work should support a good life – not compete with it. Our culture is built on flexibility, trust, and growth, so we can thrive both professionally and personally. 

These values are supported by our supportive and encouraging culture, but also comprehensive employee benefits, including 500€/year ePassi Flex balance, and an extensive occupational healthcare and insurance package. 

While we usually work where it suits us best, including flexible remote work, it's always nice to drop by our Tampere office occasionally – to meet colleagues, collaborate, and exchange updates. 

We're not just offering a job - we're offering a chance to grow, lead, and make an impact in an internationally expanding health tech company. 

Ready to make a difference? 

Apply by 31st of May 2026, and let's shape the future of diagnostics together. Salary range for this position is 5000-5600€/month. 

Got any questions? Contact our recruiter Jaana: jaana.perholehto@mylab.fi.